Clinical trial · Observational
Study of Cardiopulmonary Exercise Testing in Women Who Have HER2-Positive Breast Cancer With Mild Cardiotoxicity
A Pilot Study of Cardiopulmonary Exercise Testing in Patients With Left Ventricular Systolic Dysfunction Receiving HER2-Targeted Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out how much oxygen is used during a cardiopulmonary exercise test (CPET) in women who have mild cardiotoxicity after standard treatment for HER2-positive breast cancer, and to see whether the results of this test can be used to predict how well participants' heart and lungs will work if they continue to receive this kind of treatment.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage III | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Cardiotoxicity | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| HER2-positive Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiopulmonary Exercise Test | Diagnostic Test | — | UNRESOLVED |
| Echocardiogram | Diagnostic Test | — | UNRESOLVED |
| Echocardiography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with HER2-positive breast cancer
- description
- Participants with HER2-positive breast cancer who have developed mild cardiotoxicity during HER2-targeted therapy, defined by a decline in LVEF \> 10% to \< 53% without symptoms of clinical heart failure (NYHA class III or IV), will be eligible for participation in this study.
- interventionNames
- Diagnostic Test: Cardiopulmonary Exercise Test
- Diagnostic Test: Echocardiogram
- Diagnostic Test: Echocardiography
Primary outcomes (1)
- measure
- Baseline VO2peak in participants with HER2-positive breast cancer
- timeFrame
- At baseline
- description
- The primary purpose is to evaluate baseline VO2peak in patients with HER2-positive solid tumors and left ventricular systolic dysfunction
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Female * Diagnosed with a HER2-positive solid tumor (stage I-IV) * Left ventricular dysfunction prior to the start of HER2-targeted therapy, defined by a LVEF \< 53% (or lower limit of normal), or diagnosed with mild cardiotoxicity associated with HER2-targeted therapy, defined by an absolute decrease in LVEF ≥ 10% from pre-treatment to \< 53% * Planning to undergo treatment with HER2-targeted therapy (e.g. trastuzumab, pertuzumab, or ado-trastuzumab) for a minimum of 3 months (i.e. 4 cycles administered every 3 weeks). * Willing and able to comply with the requirements of the protocol Exclusion Criteria: * Symptomatic heart failure (New York Heart Association Class III or IV) * Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing: * Acute myocardial infarction (within 30 days of any planned study procedures), * Unstable angina * Uncontrolled arrhythmias causing symptoms or hemodynamic compromise, * Symptomatic severe aortic stenosis * Recurrent syncope * Active endocarditis * Acute myocarditis or pericarditis * Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures) * Thrombosis of lower extremities (within 3 months of any planned study procedures) * Suspected dissecting aneurysm * Uncontrolled asthma * Pulmonary edema * Room air desaturation at rest ≤ 85% * Respiratory failure * Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) * Mental impairment leading to inability to cooperate. * Enrollment onto any other interventional investigational study * Inability to provide informed consent
References
Publications (0)
Data not yet available